drugset / Trial / NCT02577718
Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution
Phase 1/2
Completed
60 enrolled
Novel Anti-Infective Technologies, LLC
M.D. Anderson Cancer Center · collab
NaSingle-groupOpen-labelPrevention
Summary
The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated bloodstream infection (CLABSI). * The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution. * The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.
Timeline
- Start
- 2015-11
- Primary completion
- 2016-06-22
- Completion
- 2016-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitroglycerin | Unknown | 15 ug/ml | Other |
| Subject | Nitroglycerin | Unknown | 30 ug/ml | Other |
| Background | Alcohol | Other / unclassified | 22 % | Other |
| Background | sodium citrate | Unknown | 4 % | Other |